The Food and Drug Administration (FDA) has approved a new indication for Novo Nordisk’s popular weight loss drug Wegovy to help prevent heart attacks, strokes, and other cardiovascular diseases in overweight or obese adults with heart disease. Expanded use.

This approval is based on studies demonstrating that Wegovy significantly reduces the risk of serious cardiovascular events. The study showed that people who had heart disease and were diagnosed as overweight or obese were 20% less likely to experience such problems compared to patients who took a placebo.

“This patient population is at high risk for cardiovascular death, heart attack, and stroke,” John Sharetz, MD, director of the Division of Diabetes, Dyslipidemia, and Obesity in the FDA’s Center for Drug Evaluation and Research, said in a press release. . “Providing treatment options that are proven to reduce this cardiovascular risk is a major advance for public health.”

This injectable treatment is already FDA-approved for chronic weight management in adults with a body mass index (BMI) of 27 kg/m3.² Adults with a BMI of 30 kg/m or more who have at least one weight-related disease such as high blood pressure, type 2 diabetes, or high cholesterol.² that’s all. Children over 12 years of age who are obese may also be eligible to receive this drug.

lifesaving approval

The main benefit of this approval is that it expands the number of patients who can access Wegovy, said Mir Ali, M.D., bariatric surgeon and medical director of MemorialCare Surgical Weight Loss Center at Orange Coast Medical Center in Fountain Valley, California. he told Berrywell.

“The main benefit is that if a patient [previously] Although he meets the criteria based on his weight alone, he is considered overweight and suffers from heart disease, so he is now prescribed this medication,” Ali said.

He added that Wegovy’s approval has the potential to extend lifespans by simultaneously addressing obesity and heart disease, two of the leading causes of preventable death.

Michael Chan, M.D., an interventional cardiologist at Providence St. Joseph Hospital in Orange County, California, said the approval gives health care providers new tools to combat the growing heart disease epidemic in the United States. It will also be offered, he told Berrywell in an email.

Chan added that FDA approval could expand insurance coverage for expensive drugs.

“Most insurance companies, including Medicare, currently do not cover weight loss drugs,” Chan says. “This FDA expansion may lead some insurance companies to expand coverage for patients at high cardiovascular risk.”

Access may not be easy

FDA approval will make Wegovy available to more patients, which could lead to further drug shortages, especially given previous drug shortages due to increased demand, Ali said.

“This drug is already in short supply and I don’t think manufacturers will necessarily increase production,” Ali said. “Due to its wide indication, demand will increase even more. Therefore, this drug may become even more scarce.”

Another potential downside of FDA approval is that the drug’s list price could remain high or even increase, Ali said. Because the process of development and FDA approval involves significant research and development costs, pharmaceutical companies may adjust the price of their drugs to recover these costs.

“It’s a long and expensive process to get FDA approval, and drug companies want their money back,” Ali said. “This could likely result in higher out-of-pocket costs or other issues. [for the patient] when getting medicine. ”

How does Wegovy work to reduce the risk of cardiovascular disease?

Wegovy works by mimicking a hormone naturally present in the body called GLP-1. “We are very excited to have the opportunity to help patients with this disease,” said Dr. Chen, a board-certified interventional cardiologist and director of the Structural Heart Program at Memorial Care Saddleback Medical Center in Laguna Hills, California. very well.

GLP-1 is a hormone that sends signals to the brain that induce satiety, leading to a decrease in food intake. It also slows down the rate at which the stomach empties its contents into the small intestine, making you feel fuller for longer.

Feeling full can help you lose weight, which is important in managing conditions such as diabetes, high blood pressure, and chronic inflammation. This may have a positive impact on cardiovascular health, but other heart health mechanisms may also be at play.

“If you can reduce risk factors such as excess weight, high blood sugar, and high blood pressure, you can reduce your risk of heart disease,” Chen says. “Over time, the risk of endpoints such as heart attack and stroke also decreases.”